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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TBS | Experimental | Daily, 4-week, 5-days per week treatment sessions, each consisting of: First, intermittent TBS (iTBS) over the L-DLPFC: triplet 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, (600 pulses per session, total duration of 3 min 9 s), then continuous TBS (cTBS) over the R-DLPFC as 40 s uninterrupted bursts (600 pulses). Intensity at 120% resting motor threshold (RMT). |
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| Sham TBS | Sham Comparator | Daily, 4-week, 5-days per week treatment sessions. The sham coil will generate auditory and somatosensory (vibratory) stimuli identical to the active stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TBS | Device | MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Scale for Suicidal Ideation Remission | A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome. | Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scale for Suicidal Ideation Change | A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome. | Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up |
| Change in Columbia - Suicide Severity Rating Scale Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daphne Voineskos, MD, PhD | Clinician Scientist, Psychiatrist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40040511 | Derived | Tang VM, Le Foll B, Daskalakis ZJ, Wang AL, Buckley L, Blumberger DM, Voineskos D. Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: a pilot feasibility randomized controlled trial. Eur Psychiatry. 2025 Mar 5;68(1):e63. doi: 10.1192/j.eurpsy.2025.28. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009293 | Opioid-Related Disorders |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| Sham TBS | Device | MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark) |
|
An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome |
| Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up |
| 17-item Hamilton Rating Scale for Depression (HRSD-17) Change | A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome | Baseline, after TBS treatment course (4 weeks), and at 1 month follow up |
| Visual Analogue Scale for Opioid Cravings Change | A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome. | Baseline, after TBS treatment course (4 weeks), and at 1 month follow up |
| Timeline Followback Change | Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome. | Baseline, after TBS treatment course (4 weeks), and at 1 month follow up |
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |